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New drug combo aims to extend remission in ovarian cancer

NCT ID NCT07225270

Disease control Sponsor: Genmab Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 6 times

Summary

This Phase 3 trial tests whether adding the experimental drug Rina-S to standard care (bevacizumab or monitoring) can help keep platinum-sensitive ovarian cancer from returning after chemotherapy. About 528 participants will receive either Rina-S alone, Rina-S plus bevacizumab, bevacizumab alone, or monitoring only. The study measures how long the cancer stays under control and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rinatabart sesutecan (Rina-S) and bevacizumab
What this could lead to
If successful, this could offer a new maintenance option to help keep platinum-sensitive ovarian cancer from returning after chemotherapy.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet proven. Side effects from Rina-S or bevacizumab may occur, and the combination may not improve outcomes over standard care alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 544 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer. * Must have PSOC defined as progressive disease \> 6 months (ie, 183 days) from the last dose of primary (first-line \[1L\]) platinum therapy. * Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who achieved complete response (CR)/no clinical evidence of disease (NED) or partial response (PR) following 1L platinum-based chemotherapy regimen must have previously received PARPi maintenance therapy as part of their 1L treatment. * Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC. * Must be randomized no later than 8 weeks from the last dose of the 2L platinum-based therapy. * Participants must have achieved a CR/NED, PR; or SD permitted only if bevacizumab was given in 2L in combination with platinum-based chemotherapy, as assessed by the investigator, following completion of 2L platinum-based chemotherapy. Key Exclusion Criteria: * Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors * More than 2 prior lines of systemic therapy. * Progression while on or following 2L platinum-based regimen prior to randomization. * Participants who receive an intervening systemic anticancer treatment (excluding bevacizumab) after the last dose of 2L platinum-based chemotherapy and prior to randomization. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer ovarian cancer ovarian carcinoma ovarian endometrioid adenocarcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma primary sclerosing cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian cancer Platinum-sensitive ovarian cancer PSOC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Greater Baltimore Medical Center

    RECRUITING

    Towson, Maryland, 21204, United States

  • Hyogo Cancer Center

    RECRUITING

    Akashi, Hyōgo, Japan

  • Kanagawa Prefectural Cancer Center

    RECRUITING

    Yokohama, Japan

  • Kitasato University Hospital

    RECRUITING

    Sagamihara, Japan

  • Kurume University Hospital

    RECRUITING

    Kurume, Japan

  • Miami Valley Hospital South

    RECRUITING

    Centerville, Ohio, 45459, United States

  • Mie University Graduate School Of Medicine

    RECRUITING

    Tsu, Mie-ken, Japan

  • Mt. Sinai Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33140, United States

  • National Hospital Organization Hokkaido Cancer Center

    RECRUITING

    Sapporo, Hokkaido, Japan

  • Niigata University Medical & Dental Hospital

    RECRUITING

    Niigata, Japan

  • Okayama University Hospital

    RECRUITING

    Okayama, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    RECRUITING

    Takatsuki, Osaka, Japan

  • Saitama Medical University International Medical Center

    RECRUITING

    Hidaka, Saitama, Japan

  • Sapporo Medical University Hospital

    RECRUITING

    Sapporo, Hokkaido, Japan

  • Sarasota Memorial Health Care System

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-chō, Japan

  • St Marianna University School of Medicine

    RECRUITING

    Kawasaki, Japan

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Tokyo, Japan

  • The Jikei University Kashiwa Hospital

    RECRUITING

    Kashiwa, Japan

  • Tohoku University Hospital

    RECRUITING

    Sendai, Japan

  • UZ Leuven - Gasthuisberg Campus

    RECRUITING

    Leuven, Belgium

  • Zangmeister Cancer Center

    RECRUITING

    Columbus, Ohio, 43219, United States

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